Binge Eating, Obesity
Conditions
Brief summary
The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.
Detailed description
This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.
Interventions
DEVICEOTX-401
Evidence-based treatments for obesity and binge eating
Sponsors
National Institute of Mental Health (NIMH)
Oui Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. English speaking male or female patients, 18-70 years 2. Patients with recurrent binge eating (≥12 episodes in 3 months) and obesity (BMI ≥30) 3. Understand written and spoken English 4. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher 5. Willing and able to complete enrollment procedures 6. Able to understand the nature of the study and provide written informed consent
Exclusion criteria
1. Patients with active psychosis 2. Patients who are acutely intoxicated at the time of enrollment 3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted 4. Patients who are cognitively impaired 5. Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Sale (SUS) | Week 12 | The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability. |
Contacts
Primary ContactBrian Keenaghan
Outcome results
None listed